Cleared Traditional

K082619 - SILS PORT

K082619 is an FDA 510(k) clearance for SILS PORT, manufactured by Covidien Lp, Formerly Registered AS United States. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K082619 · Covidien Lp, Formerly Registered AS United States · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
59d
Days
Class 2
Risk

K082619 is an FDA 510(k) clearance for the SILS PORT, MODELS SILSPT5, SILSPT12. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Covidien Lp, Formerly Registered AS United States (North Haven, US). The FDA issued a Cleared decision on November 7, 2008 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Covidien Lp, Formerly Registered AS United States devices

FDA 510(k) Submission Details - K082619

510(k) Number K082619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2008
Decision Date November 07, 2008
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 724
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K082619.
VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550
K083194 · Terumo Cardiovascular Systems Corp. · Jan 2009
FIXATION TROCARS
K083638 · Applied Medical Resources Corp. · Dec 2008
AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS
K082322 · Covidien · Nov 2008
STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV)
K081995 · Stryker Endoscopy · Oct 2008
ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213
K082156 · Teleflex Medical · Sep 2008
MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS
K080257 · Medtronic Xomed, Inc. · May 2008